S. 2730: Kidney Care Access Protection Act

This bill, known as the Kidney Care Access Protection Act, aims to enhance access to innovative treatments for individuals with end-stage renal disease (ESRD) under the Medicare program. It includes several key provisions aimed at improving the payment system for dialysis-related services and ensuring that patients can utilize new therapies and technologies effectively.

Title I – Protecting Patient Access to Kidney Care Innovation

Section 101 – Refining the End-Stage Renal Disease Payment System

The bill proposes to extend the Transitional Drug Add-On Payment Adjustment (TDAPA) for new renal dialysis drugs and biological products for at least three years. This extension helps ensure that providers can receive additional payments for products approved starting January 1, 2020, that qualify for this adjustment and are used on or after January 1, 2026.

Additionally, the bill seeks to establish a permanent payment adjustment for new renal dialysis drugs administered beginning January 1, 2024, as part of the end-stage renal disease (ESRD) prospective payment system. This adjustment will be based on recent utilization data and sales prices of these drugs and will be updated annually to reflect inflation.

Section 102 – Supporting Innovative Therapies in Medicare Advantage

This section specifies that starting January 1, 2026, providers of services or renal dialysis facilities will receive payment adjustments for innovative renal dialysis drugs and devices under Medicare Advantage. The payment will be equivalent to what is established under the ESRD prospective payment system for the duration of the transitional payments.

Title II – Addressing Staffing Barriers with ESRD Market Basket Labor Adjustments

Section 201 – Ensuring Accuracy and Stability in Kidney Care Payment

The bill introduces a mechanism to adjust payment amounts for renal dialysis services by taking into account forecast errors in pricing for goods and services used in these services. Specifically, it mandates an annual adjustment to account for discrepancies between forecasted and actual price changes, with the first adjustment reflecting cumulative forecast errors from prior years.

Effective Date

The provisions outlined in this bill will become effective on January 1, 2026, which means any changes will apply to items and services provided on or after that date.

Relevant Companies

• FREY - Frey, a company involved in kidney care technologies, may benefit from expanded payment options for new dialysis devices.
• LEQN - Leap, a manufacturer of renal pharmaceuticals, could see increased reimbursement for its dialysis drugs under the extended payment adjustments.